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Remedy Spacer

Model RSHHSM · OSTEOREMEDIES, LLC · DI 00855195006432

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660

MBB — Bone Cement, Antibiotic · Class II · 21 CFR 888.3027

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12342019-01: 0 reports for this device; peer average 2.09/device2019-02: 0 reports for this device; peer average 2.2/device2019-03: 0 reports for this device; peer average 1.99/device2019-04: 0 reports for this device; peer average 2.06/device2019-05: 0 reports for this device; peer average 2.07/device2019-06: 0 reports for this device; peer average 2.47/device2019-07: 0 reports for this device; peer average 2.08/device2019-08: 0 reports for this device; peer average 3.63/device2019-09: 0 reports for this device; peer average 2.65/device2019-10: 0 reports for this device; peer average 4/device2019-11: 0 reports for this device; peer average 4.01/device2019-12: 0 reports for this device; peer average 3.43/device2020-01: 0 reports for this device; peer average 4.27/device2020-02: 0 reports for this device; peer average 2.9/device2020-03: 0 reports for this device; peer average 2.65/device2020-04: 0 reports for this device; peer average 2.15/device2020-05: 0 reports for this device; peer average 1.9/device2020-06: 0 reports for this device; peer average 2.32/device2020-07: 0 reports for this device; peer average 2.2/device2020-08: 0 reports for this device; peer average 1.93/device2020-09: 0 reports for this device; peer average 2.23/device2020-10: 0 reports for this device; peer average 2.21/device2020-11: 0 reports for this device; peer average 2.8/device2020-12: 0 reports for this device; peer average 2.25/device2021-01: 0 reports for this device; peer average 2.26/device2021-02: 0 reports for this device; peer average 2.22/device2021-03: 0 reports for this device; peer average 2.65/device2021-04: 0 reports for this device; peer average 2.73/device2021-05: 0 reports for this device; peer average 2.32/device2021-06: 0 reports for this device; peer average 2.09/device2021-07: 0 reports for this device; peer average 2.31/device2021-08: 0 reports for this device; peer average 2.25/device2021-09: 0 reports for this device; peer average 1.9/device2021-10: 0 reports for this device; peer average 2.05/device2021-11: 0 reports for this device; peer average 2.16/device2021-12: 0 reports for this device; peer average 2.05/device2022-01: 0 reports for this device; peer average 2.25/device2022-02: 0 reports for this device; peer average 2.08/device2022-03: 0 reports for this device; peer average 1.96/device2022-04: 0 reports for this device; peer average 2.1/device2022-05: 0 reports for this device; peer average 1.94/device2022-06: 0 reports for this device; peer average 2.03/device2022-07: 0 reports for this device; peer average 2.23/device2022-08: 0 reports for this device; peer average 2.04/device2022-09: 0 reports for this device; peer average 1.86/device2022-10: 0 reports for this device; peer average 2.04/device2022-11: 0 reports for this device; peer average 2.1/device2022-12: 0 reports for this device; peer average 1.87/device2023-01: 0 reports for this device; peer average 1.71/device2023-02: 0 reports for this device; peer average 1.94/device2023-03: 0 reports for this device; peer average 2.07/device2023-04: 0 reports for this device; peer average 1.95/device2023-05: 0 reports for this device; peer average 2.02/device2023-06: 0 reports for this device; peer average 2.31/device2023-07: 0 reports for this device; peer average 2.06/device2023-08: 0 reports for this device; peer average 1.97/device2023-09: 0 reports for this device; peer average 1.56/device2023-10: 0 reports for this device; peer average 1.58/device2023-11: 0 reports for this device; peer average 1.63/device2023-12: 0 reports for this device; peer average 1.44/device2024-01: 0 reports for this device; peer average 2.09/device2024-02: 0 reports for this device; peer average 1.85/device2024-03: 0 reports for this device; peer average 1.7/device2024-04: 0 reports for this device; peer average 1.77/device2024-05: 0 reports for this device; peer average 1.81/device2024-06: 0 reports for this device; peer average 1.93/device2024-07: 0 reports for this device; peer average 1.63/device2024-08: 0 reports for this device; peer average 1.75/device2024-09: 0 reports for this device; peer average 1.73/device2024-10: 0 reports for this device; peer average 1.66/device2024-11: 0 reports for this device; peer average 1.64/device2024-12: 0 reports for this device; peer average 1.7/device2025-01: 0 reports for this device; peer average 1.73/device2025-02: 0 reports for this device; peer average 1.58/device2025-03: 0 reports for this device; peer average 1.88/device2025-04: 0 reports for this device; peer average 1.64/device2025-05: 0 reports for this device; peer average 1.8/device2025-06: 0 reports for this device; peer average 1.84/device2025-07: 0 reports for this device; peer average 1.72/device2025-08: 0 reports for this device; peer average 1.53/device2025-09: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 1.66/device2025-11: 0 reports for this device; peer average 1.71/device2025-12: 0 reports for this device; peer average 2.12/device2026-01: 0 reports for this device; peer average 1.9/device2026-02: 0 reports for this device; peer average 1.81/device2026-03: 0 reports for this device; peer average 1.75/device2026-04: 0 reports for this device; peer average 1.71/device2026-05: 0 reports for this device; peer average 1.75/device2026-06: 0 reports for this device; peer average 1.69/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.09
2019-0202.2
2019-0301.99
2019-0402.06
2019-0502.07
2019-0602.47
2019-0702.08
2019-0803.63
2019-0902.65
2019-1004
2019-1104.01
2019-1203.43
2020-0104.27
2020-0202.9
2020-0302.65
2020-0402.15
2020-0501.9
2020-0602.32
2020-0702.2
2020-0801.93
2020-0902.23
2020-1002.21
2020-1102.8
2020-1202.25
2021-0102.26
2021-0202.22
2021-0302.65
2021-0402.73
2021-0502.32
2021-0602.09
2021-0702.31
2021-0802.25
2021-0901.9
2021-1002.05
2021-1102.16
2021-1202.05
2022-0102.25
2022-0202.08
2022-0301.96
2022-0402.1
2022-0501.94
2022-0602.03
2022-0702.23
2022-0802.04
2022-0901.86
2022-1002.04
2022-1102.1
2022-1201.87
2023-0101.71
2023-0201.94
2023-0302.07
2023-0401.95
2023-0502.02
2023-0602.31
2023-0702.06
2023-0801.97
2023-0901.56
2023-1001.58
2023-1101.63
2023-1201.44
2024-0102.09
2024-0201.85
2024-0301.7
2024-0401.77
2024-0501.81
2024-0601.93
2024-0701.63
2024-0801.75
2024-0901.73
2024-1001.66
2024-1101.64
2024-1201.7
2025-0101.73
2025-0201.58
2025-0301.88
2025-0401.64
2025-0501.8
2025-0601.84
2025-0701.72
2025-0801.53
2025-0901.5
2025-1001.66
2025-1101.71
2025-1202.12
2026-0101.9
2026-0201.81
2026-0301.75
2026-0401.71
2026-0501.75
2026-0601.69
This device (reports/month)Average device in KWS, MBB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K152267 — cites (transitively): K040432 (d1), K042021 (d1), K060535 (d1), K061454 (d1), K062273 (d1), K062274 (d1), K071032 (d1), K103466 (d1), K112470 (d1), K112983 (d1), K131135 (d1), K140063 (d1), K052990 (d2), K060692 (d2) — cited as predicate by K240856, K252443

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — OSTEOREMEDIES, LLC

  • NAI 2022-04-06 Osteoremedies, LLC · 0 citations
  • NAI 2022-04-06 Osteoremedies, LLC · 0 citations
  • NAI 2016-06-07 Osteoremedies, LLC · 0 citations
  • NAI 2016-06-07 Osteoremedies, LLC · 0 citations